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Advances in Drug-Diagnostic Co-Development

  • Publication Date:May 2011
  • Publisher:Business Insights
  • Product Type: Report
  • Pages:102

Advances in Drug-Diagnostic Co-Development

Introduction

This report provides in depth analysis of the current and evolving regulatory framework for drugs and diagnostics in the US and EU and specific guidance for their co-development. Advances in biomarker development and validation are assessed and case studies given of regulatory approvals of drugs and companion tests. Strategies for drug-diagnostic co-development are evaluated.

Features and benefits

  • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development.
  • Understand the biomarker discovery and validation process.
  • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU.
  • Discover the various types of collaborations used by pharma and diagnostic companies.
  • Assess the impact of drug-diagnostic co-development on key stakeholders including the industry, regulators, physicians, and pharmacy benefit managers.

Highlights

The regulatory landscape for drug-diagnostic co-development projects is evolving. The FDA and EMA both have similar biomarker qualification processes in place that enable companies to obtain advice or qualification of the biomarker in question and the agenices have published their current thinking in relation to drug-diagnostic co-development.

Changes to diagnostics regulation in the EU and US are under discussion and are viewed as critical given the pivotal and game changing role of diagnostics in the future of healthcare. Both the FDA and lawmakers in the US are taking steps to address the problems with the current system and a public consulation recently completed in the EU.

The lack of clarity around regulations for drug-diagnostic co-development is only one of the hurdles facing the commercialisation of companion diagnostics. Market acess issues provide another major hurdle as clear pathways to gaining value-based reimbursement for high value molecular diagnostic tests are not available.

Your key questions answered

  • How is the regulatory landscape for drug-diagnostic co-development evolving in the US and Europe?
  • How do the FDA and EMA qualify biomarkers prior to their inclusion in a diagnostic procedure?
  • How can pharma and diagnostic companies make collaborations between them work for both parties?
  • How has the type of deal between pharma and diagnostic companies changed over the last six years?
  • How can key stakeholders including industry, regulators, and physicians benefit from the introduction of drug-diagnostic developments
  • Executive Summary
    • Introduction
    • Drug-diagnostic co-development: from concept to reality
    • New pathways and regulatory change
    • Strategies for drug-diagnostic co-development in pharma R&D
    • Stakeholder perspectives on regulatory change: outlook for pharma and diagnostics
  • About the Authors
    • Sara Sleigh
    • Cheryl L Barton
    • Disclaimer
  • Introduction
    • Summary
    • Introduction
    • Regulatory framework for drugs and diagnostics in the US
      • Biomarker guidance
      • Drug-diagnostic co-development guidance
      • FDA organization
      • Drug and biologics regulation by the FDA
      • Diagnostics regulation by the FDA
    • Regulatory framework for drugs and diagnostics in the EU
      • EMA guidance for personalized medicine
      • Drug and biologics regulation by the EMA
      • Diagnostics regulation in the EU
    • Comparing and contrasting regulation in the EU and US: drivers for change
    • Report outline
  • Drug-diagnostic co-development: from concept to reality
    • Summary
    • Biomarkers and companion diagnostics in drug development
    • Stages of drug-diagnostic co-development
      • Biomarker discovery
      • Analytical validation
      • Clinical validation and clinical utility
    • Regulatory approvals of drugs and companion diagnostic tests
      • Drug-diagnostic co-development: Selzentry
      • Introducing companion diagnostic tests for efficacy post-approval
      • Omapro (Chemgenex): a case study
      • Introducing companion diagnostics for safety reasons
    • Labeling considerations
    • Conclusions
  • New pathways and regulatory change
    • Summary
    • Introduction
    • Biomarker qualification
      • Biomarker qualification: FDA
      • Biomarker qualification: EMA
    • FDA guidance on drug-diagnostic co-development
      • FDA-industry discussion of the drug-diagnostic co-development concept paper
      • New FDA guidance documents relating to co-development
    • Changes to device regulations in the US
      • Changes at the FDA
      • Proposed legislative changes
    • EMA guidance on drug-diagnostic co-development
    • Changes to device regulations in the EU
    • Conclusions
  • Strategies for drug-diagnostic co-development in pharma R&D
    • Summary
    • Introduction
      • Partnership for a specific drug-diagnostic co-development programs
      • Broad partnership: the preferred provider route
      • Licensing
      • In-house diagnostics development
      • The widening role of CROs
    • Conclusions
  • Stakeholder perspectives on regulatory change: outlook for pharma and diagnostics
    • Summary
    • Introduction
    • Regulators
    • Pharma industry
    • Diagnostics industry
    • Patients
    • Physicians
    • Payers
    • Emerging stakeholders
      • Pharmacy benefit managers
      • Next generation sequencing companies
      • Health IT companies
    • Conclusions and outlook
  • Appendix
    • Research methodology
    • Acknowledgements
    • Abbreviations
    • Glossary
    • References
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